FDA posts a catalog of regulatory science tools to help sponsors assess new medical devices.
FDA issues an emergency use authorization to Yale School of Public Health for its SalivaDirect Covid-19 diagnostic test.
Federal Register notice: FDA sends to OMB an information collection extension for Food and Drug Administration Rapid Response Surveys (OMB Control Num...
President Trump turns some attention to an extract from the oleander plant as an unproven cure for Covid-19, leading to speculation that he may be qui...
Federal Register notice: FDA issues a final guidance on ClinicalTrials.com civil money penalties.
FDA alerts clinical laboratory staff and health care providers about a risk of false results with Thermo Fisher Scientific TaqPath Covid-19 Combo Kit.
FDA accepts for review a Myovant Sciences NDA for its once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindr...
FDA approves a Genentech BLA for Enspryng (satralizumab-mwge) for treating neuromyelitis optica spectrum disorder in adults with a particular antibody...